Vascular plug delivery system

• US 5,320,639 A
• Filed: 03/12/1993
• Issued: 06/14/1994
• Est. Priority Date: 03/12/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Meadox Medicals, Inc. (Boston Scientific Corporation)
• Inventors: Rudnick, James J.
• Primary Examiner(s): ASCHENBRENNER, PETER
• Application Number:
  US08/030,660
• Time in Patent Office: 459 Days
• Field of Search: 606/213, 606/215, 606/216, 606/228-232, 604/13, 604/15, 604/51, 604/60, 604/158
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61L 31/044 Collagen

Abstract

A vascular plug delivery system for in vivo delivery of a vascular plug to the site of a puncture in a blood vessel. The device utilizes flashback to ensure that the plug is properly positioned adjacent the puncture prior to delivery of such plug, thereby ensuring complete hemostasis of the puncture.

Claims

1. A device for in vivo delivery of a vascular plug to a site of a puncture in a blood vessel in which a guidewire has been inserted, comprising:

a cannula capable of passing over a guidewire and having sufficient length and dimension to enter a blood vessel puncture;

a vascular plug disposed in a delivery position over the outside diameter of said cannula; and

means carried by the cannula for retaining said plug at a vessel puncture site during withdrawal of said cannula from the site of the puncture.

2. The device according to claim 1, wherein said cannula is introduced into said blood vessel through a tissue channel, and wherein said plug has a shaped forward end which facilitates introduction of said device by gradually dilating said tissue channel from a diameter corresponding to said cannula to a diameter corresponding to said plug.

3. The device according to claim 2, wherein said plug is provided with a coating for facilitating entry of said device.

4. The device according to claim 2, wherein said plug is made of a swellable material.

5. The device according to claim 2, wherein said plug is made of a compressible material.

6. The device according to claim 2, wherein said plug is made of a resorbable material.

7. The device according to claim 2, wherein said plug is made of collagen.

8. The device according to claim 1, further comprising a guidewire, and wherein said guidewire has an outside diameter less than the inside diameter of said cannula whereby flashback of blood occurs in a flow space between said guidewire and said cannula when said cannula enters said puncture.

9. The device according to claim 8, wherein the ratio between the outside diameter of said guidewire and the inside diameter of said cannula is from about 1:

1.1 to 1;

1.7.

10. The device according to claim 9, wherein the ratio between the outside diameter of said guidewire and the inside diameter of said cannula is about 1:

1.35.

11. The device according to claim 10, wherein said guidewire has an outside diameter of about 0.035 inches.

12. A device for in vivo delivery of a vascular plug to a site of a puncture in a blood vessel in which a guidewire has been inserted, comprising:

a cannula capable of passing over a guidewire and having sufficient length and dimension to enter a blood vessel puncture;

a vascular plug disposed in a delivery position over the outside diameter of said cannula;

a housing adapted to slide over said cannula and having sufficient space therein to accommodate said vascular plug; and

means carried by the cannula for retaining said plug at a vessel puncture site during withdrawal of said housing and said cannula from said site.

13. The device according to claim 12, wherein said housing is configured to protect and facilitate delivery of said plug during delivery.

14. The device according to claim 13, wherein said housing includes a front end portion designed to open upon the application of force thereto and allow delivery of said plug to said vessel puncture site.

15. The device according to claim 14, wherein said front end is beveled at an angle with respect to an axis passing through said cannula.

16. The device according to claim 14, wherein said housing includes a flange attached to its rearward end to facilitate withdrawal of said housing.

17. The device according to claim 12, wherein said means for retaining is a plug retaining tube concentric with and circumferentially surrounding said cannula.

18. The device according to claim 17, wherein said retaining tube has an outside diameter less than the inside diameter of said housing so that said retaining tube may slide within said housing and contact said plug.

19. The device according to claim 12, wherein said vascular plug is manufactured from a material that expands outward upon release from said housing.

20. The device according to claim 12, wherein said vascular plug is manufactured from an resorbable material.

21. The device according to claim 12 wherein said vascular plug is made of collagen.

22. The device according to claim 12, further comprising a hub assembly connected to the rear portion of said cannula.

23. The device according to claim 12, further comprising a guidewire, and wherein said guidewire has a diameter less than the inside diameter of said cannula whereby flashback of blood occurs when said cannula enters said puncture.

24. The device according to claim 23, wherein the ratio between the outside diameter of said guidewire and the inside diameter of said cannula is from about 1:

1.1 to 1;

1.7.

25. The device according to claim 24, wherein the ratio between the outside diameter of said guidewire and the inside diameter of said cannula is about 1:

1.35.

26. The device according to claim 25, wherein said guidewire has an outside diameter of about 0.035 inches.

27. A method for in vivo delivery of a vascular plug to a site of a puncture in a blood vessel comprising:

advancing a cannula having a plug disposed over its outside diameter to a vessel puncture site over a guidewire previously positioned in said vessel until said cannula enters said vessel and a flashback of blood is observed whereby it may be determined that said plug is positioned proximal said vessel puncture site;

depositing said plug in a position proximal said vessel puncture site; and

withdrawing said guidewire and said cannula from said vessel puncture site.

28. The method according to claim 27, further comprising a housing adapted to slide over said cannula.

29. The method according to claim 28, wherein said housing surrounding said plug is first withdrawn from said vessel puncture site, and wherein said guidewire is thereafter withdrawn from said vessel puncture site, and wherein said cannula is thereafter withdrawn from said vessel puncture site.

30. The method according to claim 28, wherein said cannula is first withdrawn from said vessel puncture site, wherein said housing surrounding said plug is thereafter withdrawn from said vessel puncture site, and wherein said guidewire is thereafter withdrawn from said vessel puncture site.

31. The method according to claim 28, wherein said housing surrounding said plug is first withdrawn from said vessel puncture site, wherein said cannula is thereafter withdrawn from said vessel puncture site, and wherein said guidewire is thereafter withdrawn from said vessel puncture site.